Key information relevant to the recruitment process for the
overall study, such as dates of the recruitment period and locations

3546 infants assessed for eligibility from 3127 pregnancies. 2230 were excluded for not meeting eligibility criteria or parental permission was not granted or other reasons.

Pre-Assignment Details

Significant events and approaches for the overall study
following participant enrollment, but prior to group assignment

235 did not meet eligiblity criteria 125 did not have personnel or equipment available 699 were eligible did not have consent sought 344 were eligible but parent or guardian was not available 748 were eligible but parent or guardian denied permission to enroll 68 were eligible and had permission but were not randomized 11 had other reasons

Explanation of how the number of participants for analysis was determined.
Includes whether analysis was per protocol, intention to treat, or another method.
Also provides relevant details such as imputation technique, as appropriate.

No text entered.

Reporting Groups

Description

CPAP and Lower Range Oxygen

Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen administered in lower range (85-90%)

CPAP and Higher Range Oxygen

Continuous Positive Airway Pressure/Positive End Expiratory Pressure (CPAP/PEEP) begun in the delivery room and continuing in the NICU and oxygen adminstered in higher range (91-95%)

Early Surfactant and Lower Range Oxygen

Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in lower range (85-90%)

Early Surfactant and Higher Range Oxygen

Intubation and administration of surfactant by 1 hour of age and oxygen adminstered in higher range (91-95%)